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<div class="span index">1</div> <span><a class="" data-remote="true" data-type="html" href="/series/pursuit-the-founders-guide-to-happiness">Pursuit: The Founders' Guide to Happiness</a></span>

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Pursuit: The Founders' Guide to Happiness

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منذ 5 أياممنذ 5d ago

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Pursuit: The Founders’ Guide to Happiness , is a 12-part series hosted by Jeffrey Rosen featuring Ken Burns and leading scholars. It explores how the founders understood personal growth and lifelong learning as essential to the common good, why those ideas matter today, and how you can put them into practice.

Global Medical Device Podcast powered by Greenlight Guru

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The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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#Business #Consultants; R #Health Industry #Health and Well-Being #Health Care #Tech #Fitness #Medicine #Medical Device

Global Medical Device Podcast powered by Greenlight Guru

78 subscribers

updated منذ 27 يومًا

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417 حلقات

#Business #Consultants; R #Health Industry #Health and Well-Being #Health Care #Tech #Fitness #Medicine #Medical Device

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#421: Mastering MedTech Influence: The Power of Communication in Quality 53:27

منذ 27 يومًا53:27

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53:27

In this episode, host Etienne Nichols sits down with Lesley Worthington, an executive coach with a background in psychology, law, and over 20 years in quality and regulatory affairs. They explore the critical, yet often overlooked, role of communication in building a robust culture of quality. Lesley explains that while quality professionals possess deep technical knowledge, they often struggle to be heard because they focus on being clear and correct rather than on making others feel understood. This conversation delves into why traditional training methods fall short and how a shift in mindset can lead to better relationships and greater influence. Lesley highlights that true influence and buy-in don’t come from simply explaining things well, but from actively listening and making others feel heard. The discussion touches on common pitfalls, such as using excessive jargon, over-explaining, and failing to understand the listener's perspective. Lesley emphasizes the importance of building trust and psychological safety, which allows for open communication and the ability to ask clarifying questions without fear. She shares practical strategies, like paraphrasing to confirm understanding and moving from a "broadcast" mindset to one of curious listening. The conversation concludes with a look at the limits of traditional training, which often focuses on information over action and fails to address personal habits and emotional intelligence. Lesley describes how her coaching practice provides a personalized space for professionals to think through their specific challenges and discover their own solutions. She advocates for simple, plain language and encourages a shift from fear-based interactions to curiosity-driven ones, underscoring that the core of effective communication is a human-centric approach. Key Timestamps [02:52] - The PR Problem: Lesley addresses why skilled professionals in quality and regulatory roles often struggle to be heard, linking it to their non-direct authority and a tendency to prioritize correctness over relationships. [06:34] - The Buy-in Breakthrough: The difference between being understood and making someone feel understood is explored, revealing that true buy-in hinges on empathy and listening. [09:34] - Communication Blind Spots: This segment uncovers common, subconscious behaviors that undermine communication, such as using too much jargon, over-explaining, and failing to consider the audience's knowledge. [14:17] - The Power of Admitting 'I Don't Know': Etienne and Lesley discuss how acknowledging a lack of understanding can build trust and demonstrate self-awareness, countering the fear of appearing "dumb." [16:42] - Fear vs. Curiosity: Etienne shares his perspective on curiosity as the opposite of fear and a powerful tool for overcoming communication anxieties. [18:12] - Why Training Fails: The limitations of traditional corporate training are examined, highlighting its focus on information rather than the personalized, action-oriented work required for true behavioral change. [25:39] - The Coaching Advantage: Lesley explains how coaching helps professionals solve their own problems and gain clarity by creating a dedicated space for focused thinking and reflection. Quotes "Buy-in isn't about whether people understand; it's about whether people feel understood." — Lesley Worthington "Curiosity... I think the opposite of fear is curiosity." — Etienne Nichols Takeaways Shift from Correctness to Connection: The most effective medical device professionals understand that their influence isn't solely based on being technically correct. Instead, they build strong relationships by focusing on making others feel heard, which ultimately encourages buy-in. Plain Language is a Global Asset: In an increasingly globalized industry, avoiding jargon and using plain language is crucial. This not only enhances clarity for non-specialists but also helps prevent miscommunication across different languages and cultures. Listening as a Strategic Tool: Listening isn't passive; it's an active, strategic skill. By asking clarifying questions and paraphrasing what you've heard, you can build trust and ensure mutual understanding, leading to smoother project execution and a stronger culture of quality. Identify Your Communication Blind Spots: Many professionals have communication habits—like over-explaining or using jargon to prove credibility—that unknowingly undermine their effectiveness. Recognizing and addressing these "hidden things" is the first step toward becoming a more influential leader. Action Over Information: While traditional training provides valuable information, true change comes from putting that knowledge into practice. Personalized coaching and self-reflection are powerful tools for addressing specific, real-world communication challenges that generic courses cannot. References FDA QMS Regulation (QMSR): The episode references the FDA's new Quality Management System Regulation (QMSR) and its preamble, which includes expectations for a "culture of quality." Etienne Nichols's LinkedIn: For more insights and connections within the medical device industry, you can connect with Etienne Nichols on LinkedIn: https://www.linkedin.com/in/etienne-nichols/ . Lesley Worthington's LinkedIn: To learn more about executive coaching and communication, connect with Lesley Worthington on LinkedIn. MedTech 101 Section Curse of Knowledge: This psychological bias describes the difficulty a person has in thinking about a problem from the perspective of a less-informed person. In the context of the medical device industry, a quality or regulatory professional with a deep understanding of a topic (like a CAPA or a 483 ) might mistakenly assume that everyone else on the team shares the same level of knowledge. This leads to the use of jargon and a lack of clear explanation, which can confuse others and hinder collaboration. The "curse" is broken by consciously stepping back and using simple, everyday language that is accessible to all. Feedback Call-to-Action What are your biggest communication challenges in MedTech? Share your thoughts and topic suggestions with us. We want to hear from you! Please send your feedback, questions, or ideas directly to us at podcast@greenlight.guru . Your input helps us create the content you need most. Sponsors This episode is brought to you by Greenlight Guru , the only medical device QMS and EDC platform designed specifically for MedTech professionals. Greenlight Guru's end-to-end solution helps you streamline your quality processes and clinical trials, ensuring compliance and accelerating your time to market. To learn more about how Greenlight Guru's Quality Management Software (QMS) and Electronic Data Capture (EDC) solutions can help your company, visit www.greenlight.guru .…

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#420: MedTech Synergy: The Project Manager and Quality Professional Relationship 39:01

منذ 5 weeks39:01

39:01

In this episode, host Etienne Nichols sits down with MedTech quality expert Beth Waring to explore the often-overlooked but crucial relationship between project managers and quality professionals. They tackle the common friction points and misunderstandings that arise when these two roles intersect, and discuss why this relationship is so vital for building a successful and compliant quality management system (QMS). Beth highlights that the key to a strong partnership is open communication and mutual respect, moving away from the "quality as a police force" mentality. She emphasizes that quality is not just a department but a company-wide mindset—a concept she calls "small Q quality." The discussion provides practical insights on how project managers and quality professionals can work together effectively, ensuring that processes are flexible yet compliant. They also explore how language and tools can either help or hinder this collaboration. By reframing conversations to focus on shared goals like risk mitigation and efficiency, and by adopting user-friendly QMS solutions like Greenlight Guru's, teams can achieve better engagement and compliance. Beth shares a personal anecdote about turning a skeptic into a quality champion by simply explaining the "why" behind a procedure, underscoring the power of education and trust in fostering a culture of quality. Key Timestamps 00:02:54 - Defining a culture of quality and the friction points in implementation. 00:03:21 - The problem with "big Q" and "small Q" quality and why language matters. 00:07:05 - The ideal relationship between a project manager and a quality professional. 00:10:34 - The analogy of quality as a safety guardrail for the company. 00:11:14 - Expanding the scope of risk management beyond patient harm. 00:14:53 - Strategies for overcoming resistance and low adoption of new quality tools. 00:17:43 - The importance of involving quality professionals early in the proof-of-concept phase. 00:19:30 - Tailoring communication to different departments to enhance engagement. 00:21:21 - Beth's story about converting a skeptic into a quality champion by explaining the "why." 00:24:42 - The critical role of digital solutions in streamlining change orders and design controls. Quotes "Quality is doing the right thing when nobody's watching." "Quality can be a police force or they can be a partner. We want to make sure they're a partner." - Etienne Nichols Takeaways Foster a Culture of Collaboration: Shift the mindset from quality as a policing function to a collaborative partnership. Open communication and trust between project managers and quality professionals are essential for success and compliance. Explain the "Why": Rather than dictating procedures, take the time to explain the purpose and regulatory justification behind quality processes. When people understand the "why," they are more likely to adopt and champion the system. Flexibility is Key: A rigid QMS can lead to frustration and workarounds. Build flexibility and risk-based decision-making into your processes from the start, allowing for deviations when justified without compromising safety or compliance. Involve Quality Early: Bringing quality professionals into the R&D and proof-of-concept phases ensures that early-stage documentation is robust and controlled. This streamlined approach prevents issues and rework later in the development cycle. Leverage Modern Tools: Modern Electronic Quality Management Systems (EQMS) like Greenlight Guru's QMS and EDC solutions can transform tedious manual tasks—such as managing change orders and design controls—into an efficient, traceable process, saving time and reducing errors for the entire team. References ISO 13485: The international standard for quality management systems specific to medical devices. 21 CFR Part 820: The FDA's Quality System Regulation for medical devices. ISO 14971: The international standard for applying risk management to medical devices. IEC 62304: The standard for the software life cycle process for medical device software. Etienne Nichols's LinkedIn: https://www.linkedin.com/in/etiennenichols/ MedTech 101 Quality Management System (QMS): A QMS is a structured set of processes and procedures that a medical device company uses to ensure their products meet regulatory requirements and customer expectations. Think of it as the company's "operating manual" for quality. It outlines everything from design controls and risk management to manufacturing, change orders, and post-market surveillance. While historically paper-based, modern companies are moving toward electronic QMS (EQMS) solutions for greater efficiency and traceability. We Want Your Feedback! Thank you for tuning in to the Global Medical Device Podcast. We hope this episode provided valuable insights into the crucial collaboration between project management and quality. Have a topic you'd like us to cover? Your feedback helps us create content that is relevant and useful to you. Please send your suggestions, comments, and questions to our team at podcast@greenlight.guru . We read every message and look forward to hearing from you.…

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#419: Essential Strategies for CRO Success in Today's Clinical Landscape 30:05

منذ 6 weeks30:05

30:05

In this episode, host Etienne Nichols speaks with Greenlight Guru's Christine Wilbert, an expert in Electronic Data Capture (EDC) systems for Clinical Research Organizations (CROs). They discuss the critical factors CROs must consider when selecting an EDC solution. Christine highlights that the biggest mistake is a lack of due diligence and not planning for future needs beyond a single study. She emphasizes the importance of looking for a solution that can scale with a company's growth, from pilot studies to pivotal trials, and warns against hidden costs and inadequate post-sales support. The conversation delves into what truly matters in an EDC platform, such as intuitive design, speed of implementation, and the ability to handle repeatable processes. Christine shares that while some vendors may offer "bells and whistles," the core value lies in a lean, efficient system tailored to medical device trials. They also touch on the importance of involving all stakeholders, including site users like clinicians and healthcare professionals, to ensure system adoption and maintain data integrity. Finally, the discussion explores how an EDC system can help CROs win more business. Christine explains that having a scalable, pre-validated solution and a vendor that actively supports business development can be a significant advantage. They also cover the essential compliance features for global trials, such as FDA 21 CFR Part 11 and ISO 14155, and the growing role of hybrid and decentralized trials. Christine's final advice to CROs is to "do your due diligence" and select a solution that's a true partner for long-term success. Key Timestamps 00:02:39 - Biggest mistakes CROs make when choosing an EDC. 00:03:00 - The importance of future planning and scalability. 00:04:40 - The value of post-sales support and avoiding hidden fees. 00:05:31 - Essential features versus "vendor noise" and unnecessary bells and whistles. 00:08:11 - The analogy of a "battleship" vs. a "ninja" in problem-solving. 00:09:13 - Identifying key stakeholders for successful EDC implementation. 00:11:17 - Challenges and strategies for engaging healthcare professionals. 00:13:31 - When to start looking for an EDC solution and the typical timeline. 00:15:44 - The onboarding process and what successful companies do in the first few months. 00:18:39 - How CROs can use an EDC solution to win more business. 00:20:52 - Global compliance considerations (FDA, EU MDR) for EDC platforms. 00:23:36 - Features CROs think they need but don't (e.g., QMS integration). 00:26:03 - Adapting to hybrid and decentralized trials. 00:27:22 - The key takeaway: do your due diligence and seek a true partner. Quotes "I would say the biggest issue is lack of due diligence... they're not necessarily thinking down the line, 'how is this going to scale with this specific company that they're working with?'" "The bitterness of poor quality remains long after the sweetness of low price is forgotten." Takeaways Prioritize Scalability and Long-Term Planning: Don't choose an EDC solution just for a single pilot study. Evaluate whether the platform can handle the complexity and size of pivotal and post-market studies to avoid costly transitions in the future. Look for True Partnership, Not Just a Vendor: A successful relationship with an EDC provider goes beyond the initial sale. Seek a vendor with strong post-sales support and a willingness to collaborate on business development initiatives to help you win more sponsor business. Ensure a User-Friendly Design for All Stakeholders: An EDC system is only as good as the data entered into it. Selecting an intuitive, easy-to-use platform is crucial for ensuring adoption by clinical operations teams, data managers, and, most importantly, site users like clinicians and healthcare professionals. Confirm Global Compliance and Validation Capabilities: For CROs supporting a variety of trials, it is essential to select an EDC platform that is pre-validated and compliant with global regulations like FDA 21 CFR Part 11 and ISO 14155 for EU MDR. Focus on Core Functionalities Over "Bells and Whistles": Many platforms offer features that look good but are rarely used. A lean, purpose-built solution with essential functionalities like remote data entry, ePRO (electronic Patient Reported Outcomes), and efficient reporting is often more valuable than a system overloaded with unnecessary features. References ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice. This standard is referenced as a key compliance framework for medical device clinical trials, particularly in the European Union. FDA 21 CFR Part 11 - The part of the Code of Federal Regulations that sets forth the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. Etienne Nichols's LinkedIn - https://www.linkedin.com/in/etiennenichols/ MedTech 101 What is a Clinical Research Organization (CRO)? A Clinical Research Organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. Think of a CRO as a specialist that a medical device company hires to manage a clinical trial. They handle everything from designing the study and recruiting participants to collecting and analyzing data, allowing the device company to focus on its core business. What is an Electronic Data Capture (EDC) system? An Electronic Data Capture (EDC) system is a software platform used in clinical trials to collect, manage, and report patient data. Instead of using paper forms, researchers enter data directly into a secure electronic database. This makes the data easier to share, reduces errors, and speeds up the entire clinical trial process. It’s like moving from a paper filing system to a digital spreadsheet, but with built-in security and compliance features specifically for clinical research. Feedback Call-to-Action We want to hear from you! What topics would you like us to cover on future episodes of the Global Medical Device Podcast? Your feedback helps us create content that is most valuable to you. Send your suggestions, feedback, and questions to podcast@greenlight.guru . We read and respond to every email personally. Sponsors This episode is brought to you by Greenlight Guru , the only MedTech-specific QMS & EDC solution. Greenlight Guru helps medical device companies and CROs streamline their entire product lifecycle and clinical trial processes. By providing a modern, purpose-built platform for both Quality Management Systems (QMS) and Electronic Data Capture (EDC), Greenlight Guru ensures you have the tools to manage your clinical data and maintain compliance from a single source of truth. To learn how Greenlight Guru can accelerate your journey, visit www.greenlight.guru .…

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#418: Biocompatibility Brief - What Medical Device Companies Need to Know 29:32

منذ 7 weeks29:32

29:32

This episode offers a "biocompatibility brief" with guest Marina Daineko, a MedTech expert and chemist specializing in biological evaluations. Marina shares her perspective on the critical role of chemistry and critical thinking in assessing the safety of medical devices. The discussion highlights the need to look beyond simple pass/fail tests and delve into the nuances of raw data analysis, material composition, and manufacturing processes to uncover potential risks. Marina emphasizes that biocompatibility is not an isolated task but must be fully integrated into a company's quality management system (QMS). She explores the connection between biological safety and key QMS processes such as change management, post-market surveillance, and CAPA. The conversation also touches on the shift from a reactive to a proactive mindset in the industry, driven by new regulations like the latest revision of ISO 10993-1. Using real-world examples, Marina illustrates the importance of considering long-term patient exposure and cumulative effects. She provides clear explanations of complex concepts like the difference between extractables and leachables. Her advice to MedTech professionals is to always be curious, ask questions, and prioritize communication across all teams to ensure the safety and efficacy of medical devices. Key Timestamps 01:37 - Importance of a Biological Evaluation Plan and in-depth data analysis 03:48 - The need for critical thinking in biocompatibility, highlighted by the silver ion example 06:03 - How a chemistry background informs a deeper understanding of materials 08:06 - Real-world examples of biocompatibility risks from the Netflix documentary, The Bleeding Edge 11:20 - Discussion on cumulative effects and long-term exposure to materials 12:56 - Applying a risk-based approach beyond standard tables 15:39 - The difference between extractables and leachables 18:18 - Integrating biocompatibility into the QMS (change management, CAPA, post-market surveillance) 22:01 - The shift from reactive to proactive biocompatibility approaches 23:55 - How to explain complex biocompatibility concepts to non-technical teams Quotes "Biocompatibility is not a bubble. It must be integrated into the quality management system." - Marina Daineko "Don’t be shy and ask the questions. Stay curious... and communicate." - Marina Daineko Takeaways Go Beyond the Checklist: A biological evaluation plan and critical thinking are essential. Don't rely solely on standard pass/fail tests; analyze raw data and question unexpected results, as seen in the silver ion example. Assess Cumulative Risk: For long-term or implanted devices, consider the cumulative effect of chemicals that may leach from the device over time. Proactive risk management should account for this long-term exposure. Integrate Biocompatibility into the QMS: Biocompatibility should not be treated as a standalone task. It must be integrated with core QMS processes like change management, CAPA, and post-market surveillance to ensure continuous device safety throughout its lifecycle. Communicate Across Teams: Effective communication is paramount. Technical biocompatibility information must be translated for different teams—from regulatory and quality to marketing and sales—by highlighting the impact on deadlines, compliance, and patient safety. References Netflix Documentary, The Bleeding Edge : A documentary that exposes systemic flaws and risks within the medical device industry, featuring the case of the Essure device. ISO 10993-1: The international standard for the biological evaluation of medical devices, which is undergoing revisions to emphasize a lifecycle-based approach to safety. Etienne Nichols' LinkedIn: For more insights on MedTech and quality management, connect with Etienne at https://www.linkedin.com/in/etienne-nichols . MedTech 101: Extractables & Leachables In simple terms, extractables are all the potential chemicals that could leak out of a medical device under harsh lab conditions, like high temperatures or strong solvents. Think of it as a comprehensive stress test to find every single chemical component. Leachables, on the other hand, are the chemicals that actually leak out under normal, clinically relevant conditions. This is what a patient's body might be exposed to during the device's actual use. Regulatory bodies like the FDA often require both types of analysis to ensure a comprehensive understanding of a device's chemical profile. Feedback Call-to-Action Have thoughts on today's episode or a topic you'd like us to cover? Your feedback is invaluable. Email your comments and suggestions directly to us at podcast@greenlight.guru . We read and respond to every email. Sponsors This episode is brought to you by Greenlight Guru, the only medical device success platform designed specifically for MedTech companies. Their all-in-one platform includes both a QMS and a Clinical Data Management System (EDC), providing a single source of truth for all your product development and clinical data. By streamlining your processes, Greenlight Guru helps you get safer, higher-quality medical devices to market faster and with less risk. Greenlight Guru's platform aligns perfectly with today's discussion on integrating biocompatibility into the QMS. By providing a centralized, risk-based system, it helps teams proactively manage design controls and post-market surveillance, ensuring biological safety is considered throughout the entire device lifecycle. To learn more, visit www.greenlight.guru .…

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#417: Evaluating EQMS: A Crucial Step for Medtech Success 43:45

منذ 8 weeks43:45

43:45

This episode features host Etienne Nichols and guest Andy Rogantino, who discuss the critical timing and process for evaluating and implementing an Electronic Quality Management System (EQMS). They challenge the common "wait until something breaks" approach, emphasizing that the most effective MedTech teams integrate an EQMS early in the product lifecycle. The conversation covers the strategic and financial benefits of a well-implemented EQMS, the key stakeholders who should be involved in the evaluation process, and the core criteria for selecting the right software. Rogantino highlights the importance of a purpose-built system and shares actionable advice on turning a quality system investment into a powerful tool for collaboration, efficiency, and audit readiness. Key Timestamps 03:13 When is the right time to evaluate an EQMS? 04:27 How to prioritize an EQMS investment. 05:15 The three pillars of a MedTech company: financial, ethical, and legal/regulatory. 07:28 The dual benefits of an EQMS: reducing risk and increasing efficiency. 11:59 Who should be involved in the evaluation process? 17:32 What to look for when evaluating an EQMS. 23:13 The importance of a user-friendly interface. 26:53 Navigating the sales and demo process. 28:49 Defining clear success criteria for a QMS partnership. 31:45 What to avoid during the evaluation and purchasing process. 36:52 The compounding risk of doing nothing. 40:23 The importance of clinical data and its connection to the QMS. Quotes "When your house is already on fire, it's a little late to install some sprinklers." — Andy Rogantino. "If you're asking the question, 'should we build a QMS?', you probably should." — Etienne Nichols. Takeaways Prioritize Quality Early: Delaying an EQMS evaluation until a regulatory event or product issue occurs puts a company at a significant disadvantage. The most successful MedTech teams treat their QMS as the foundation of their business from the earliest stages of development. Include All Stakeholders: An EQMS is not just for the quality department. Involve product development, regulatory, IT, and leadership. A system that breaks down silos and promotes collaboration across the entire organization is key to long-term success. Invest for ROI: An EQMS is an investment, not an expense. It should be evaluated based on its potential to positively impact the financial bottom line by streamlining processes, reducing the risk of recalls or 483s, and accelerating time to market. Seek a Purpose-Built Solution: Avoid generic, overly-customizable QMS platforms. A system built specifically for the MedTech industry, like Greenlight Guru, provides built-in guardrails and best practices that ensure compliance with standards like ISO 13485 and 21 CFR Part 820 from day one. Evaluate for User Experience: The best software is simple and intuitive. During the evaluation process, consider how the system will feel for the people using it daily. A poor user interface can lead to low adoption and workarounds, negating the benefits of the investment. References Cardiac Arrest: Five Years as a CEO on the Feds’ Hit List by Howard Root: A recommended read for MedTech leaders on the importance of robust quality systems and regulatory compliance. 21 CFR Part 820, ISO 13485, ISO 14971, and ISO 9001: Key regulatory and quality standards that an effective MedTech EQMS should be built to handle. Etienne Nichols’ LinkedIn: linkedin.com/in/etiennenichols Andy Rogantino’s LinkedIn: linkedin.com/in/andyrogantino MedTech 101 EQMS (Electronic Quality Management System): An electronic system for managing quality processes and documents in a regulated industry. In MedTech, this software helps companies comply with standards like ISO 13485 and FDA regulations by managing design controls, risk, document control, and other quality-related activities. Audience Engagement Poll Question: When does your company typically start thinking about a QMS? A. Before development even begins. B. During the design and prototyping phase. C. When we're preparing for our first regulatory submission. D. When we receive a regulatory finding or warning letter. Feedback Call-to-Action Have thoughts on today's episode or want to suggest a future topic? We want to hear from you. Email us at podcast@greenlight.guru. Your feedback helps us deliver the most relevant and actionable content to the MedTech community. Sponsors Greenlight Guru: The leading purpose-built Electronic Quality Management System (EQMS) for medical device companies. Greenlight Guru's platform is designed to help MedTech innovators bring safer, more effective products to market faster, ensuring compliance and efficiency from day one. To learn more, visit www.greenlight.guru.…

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#416: Unpacking Common FDA Compliance Gaps: Pre-Market vs. Post-Market Realities 49:29

منذ 9 weeks49:29

49:29

In this insightful episode, Mike Drues joins host Etienne Nichols to dissect the FDA's most frequently cited compliance issues, challenging the notion that many are strictly "pre-market" concerns. They delve into the nuances of software changes, design creep, and off-label marketing, providing a critical look at how companies can avoid common pitfalls. This discussion is vital for MedTech professionals seeking to understand the true nature of FDA expectations and build more robust quality systems. Timestamps 00:04 – Introduction to common FDA compliance issues 02:02 – Discussion on FDA's policy of not naming individuals 05:45 – Mike Drues challenges the "pre-market" classification of common issues 09:20 – Documentation requirements for different device classes 11:35 – Mike’s take on the most common FDA issues (beyond the presented three) 15:40 – Root causes of common compliance problems and industry responsibility 20:00 – The role of regulation and FDA's responsibility in clarity 27:05 – Deep dive into design change and design creep 31:40 – Software changes and the "bug fix" mentality 35:45 – Marketing beyond authorized intended use with a real-world example 41:00 – Key takeaways and proactive compliance strategies Standout Quotes "If the regulation makes sense, we shouldn't need it. If the regulation doesn't make sense, we shouldn't have it." — Mike Drues. This quote encapsulates Mike's philosophy on regulatory compliance, emphasizing that true professionalism means understanding inherent needs rather than just following rules. "You have a piece of software, you have a bug, you fix the bug… Is your job done? Absolutely not." — Mike Drues. This highlights a critical oversight in software development within MedTech, stressing the importance of holistic post-fix validation to prevent unintended consequences. Top Takeaways Regulatory Misclassification: Many issues labeled by the FDA as "pre-market" (e.g., marketing beyond intended use, design creep) are fundamentally post-market compliance challenges . This distinction is crucial for companies to allocate resources effectively. Beyond Administrative Review: While administrative incompleteness accounts for a significant portion of 510(k) rejections (around 38% ), the scientific and substantial equivalence reviews are major hurdles, with approximately 75% of 510(k)s rejected initially, primarily due to lack of substantial equivalence ( 85% of those rejections). Top Post-Market Violations: Historically, the most common reasons for FDA 483s and Warning Letters relate to CAPAs (12.5%), design controls (12.5%), and complaint handling (10.5%) , collectively accounting for roughly 35% of all post-market issues. Companies should prioritize these areas. Software Change Management: Fixing a software bug is only the first step; a holistic review is essential to ensure no new problems are introduced and the device's safety, efficacy, and usability remain uncompromised. Intentionality vs. Compliance: Marketing a device beyond its authorized intended use, even if the device functionally performs beyond its cleared claims, carries significant regulatory and product liability risks. Companies should seek appropriate clearance for expanded claims rather than relying on off-label promotion. References & Links Etienne Nichols' LinkedIn Greenlight Guru Call to Action Greenlight Guru is purpose-built for MedTech. See how it can transform your quality system with a personalized walkthrough — get your demo here.…

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#415: Neurotech: Accelerating Innovation in a Complex Medical Device Vertical 33:00

منذ 10 weeks33:00

33:00

In this episode, Etienne Nichols and Matt Stratton, Director and Principal Consultant at Coalition, delve into the dynamic and complex world of neurotechnology. They discuss the expansive definition of neurotech, the significant challenges in accelerating innovation—particularly concerning regulatory frameworks and cross-functional collaboration—and how a united industry voice can overcome these hurdles to bring life-changing devices to patients faster. Timestamps 00:04 - Introduction to the episode and Matt Stratton 02:21 - Matt Stratton’s journey into neurotechnology and passion for acceleration 04:30 - Defining neurotech beyond traditional boundaries 07:11 - Major challenges preventing acceleration in neurotech 10:16 - The internal and external barriers to collaboration 13:40 - The "generalist vs. specialist" dilemma in neurotech expertise 17:03 - Optimizing existing neurotech and the future of advanced neuroscience 19:34 - What neurotech can learn from other medical device verticals 22:50 - The complexity of the brain: "What is normal?" 24:50 - Ethical considerations of neurotech advancements 26:27 - Overcoming competitive intelligence in collaborative communities 29:05 - Bridging the language gap between pharma and medical devices in neurotech 31:40 - Matt Stratton's call to action for the neurotech community 33:10 - Political challenges and maintaining focus on shared goals Standout Quotes "I think the neurotech space is a bit broader than that because there are so many interrelated areas that are relying and using very similar technologies and ultimately aiming for the same patient groups...and will come across the same regulatory structures." — Matt Stratton Matt's expansive view highlights the interconnectedness of neurotech, emphasizing that a holistic approach to defining the field is crucial for effective collaboration and regulatory navigation. "If what ties us together is greater than the soil we stand on, then yeah, we can remain standing together." — Etienne Nichols Etienne's profound statement underscores the power of shared purpose and patient-centric goals in transcending political and competitive barriers within the medical device industry. Top Takeaways Broadening the Neurotech Definition: Neurotech extends beyond neuromodulation and BCIs to include neurodiagnostics, neuromonitoring, neurological drug delivery, and neurosurgical devices. This broader perspective fosters greater collaboration and addresses common regulatory and patient needs. Challenges in Acceleration: Key hurdles include complex regulatory environments, the need for increased collaboration among diverse experts (neuroscientists, biologists, engineers), and adapting to emerging technologies like AI. The Power of External Collaboration: Bringing together different industry players helps establish a unified voice for regulatory changes, benchmark best practices, and break down barriers to faster progress, especially as neurotech pushes ethical and technological boundaries. Learning from Other Verticals: While neurotech faces unique challenges, insights from established fields like orthopedics and CRM, particularly regarding rapid product development (e.g., "Moore's Law" in tech), offer valuable lessons for accelerating innovation. Navigating Complexity and Ethics: The brain's inherent complexity and the fluid concept of "normalcy" introduce unique challenges for neurotech. This includes addressing profound ethical considerations, such as the potential for enhanced human capabilities to exacerbate societal inequalities. Fostering Open Dialogue: Community platforms that focus on "mundane" structural and regulatory challenges—rather than confidential IP—can successfully foster collaboration among competitors, demonstrating that shared non-competitive problems are abundant and fruitful for discussion. References & Links Matt Stratton LinkedIn Etienne Nichols LinkedIn Coalition Call to Action Greenlight Guru is purpose-built for MedTech. See how it can transform your quality system with a personalized walkthrough — get your demo here .…

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#414: Why Global Certification is the Future of Clinical Research in Latin America 34:49

منذ 11 weeks34:49

34:49

As global clinical trials become more competitive and data-driven, Latin America is stepping up with a new global standard in clinical trial quality. In this episode, Etienne Nichols speaks with Julio Martinez-Clark, CEO of BioAccess and a key advocate for clinical site certification in Latin America. They discuss the launch of the GCSA certification and IAOCR accreditation now available in the Americas, exploring how these standards improve site credibility, de-risk clinical trials, and offer faster pathways for medtech market access. From regulatory advantages to site selection strategies, this episode is essential listening for sponsors, CROs, and MedTech leaders navigating global trials. Key Timestamps 00:02 – Introduction to Julio Martinez-Clark and episode overview 02:10 – What is GCSA and IAOCR certification? 06:00 – Why certification is emerging now: volume, complexity, and patient safety 09:42 – Certification structure: site vs. individual requirements 13:45 – The Colombian model: First mover in Latin America 17:55 – Global harmonization vs. local certification pitfalls 21:30 – Measuring ROI of certified vs. non-certified sites 26:15 – Future of global site certification and Latin America’s role 30:00 – Regional differences: speed vs. patient pool in trial site selection 36:15 – Final thoughts on FDA trends and LATAM’s emerging position Quotes “It’s appalling that in an industry that deals with lives, there was no global standard to certify site or individual competency—until now.” – Julio Martinez-Clark Why it matters: This underscores the critical gap in clinical research infrastructure and the urgent need for standards like GCSA. “You can’t measure quality without a shared framework. Certification levels the playing field globally.” – Julio Martinez-Clark Why it matters: This highlights how global certification allows consistent benchmarking across clinical sites, benefitting sponsors and patients alike. Key Takeaways GCSA Certification Elevates Site Credibility: Clinical sites with GCSA certification are fast-tracked for sponsor consideration, leading to better trial access and more robust patient recruitment. IAOCR Accreditation Validates Individual Competency: For investigators, coordinators, and site managers, individual accreditation under the UNESCO-backed IAOCR framework offers a portable, verifiable skillset. Latin America Offers Dual Advantages: With rapid recruitment and cost-effective data generation, LATAM is uniquely positioned to lead in globally certified trials—especially Colombia, which already mandates certification. Global Harmonization is Critical: Fragmented local certifications can deter sponsors. A unified global framework like GCSA simplifies compliance, increases efficiency, and builds trust. The FDA Bottleneck May Shift Market Entry: With regulatory delays in the U.S., more medtech firms may turn to Latin America for first-in-human trials and initial commercialization. References Julio Martinez-Clark on LinkedIn Bioaccess LATAM IAOCR – International Accreditation Organization for Clinical Research Etienne Nichols on LinkedIn MedTech 101: What Is GCSA Certification? Analogy: Think of GCSA like ISO 9001, but for clinical research sites. It standardizes operational quality and ensures consistent patient safety practices across global locations. Beginner Example: If a sponsor is choosing between two hospitals, and one has a GCSA badge—it’s like choosing a restaurant with a food safety grade. It builds immediate trust. Poll Question: What’s your biggest challenge when selecting global clinical trial sites? Assessing quality Regulatory alignment Patient recruitment speed Cost All of the above Engagement Prompt: Have you worked with certified sites or accredited professionals in your clinical trials? Share your experiences or questions with us at podcast@greenlight.guru . Feedback Enjoying the Global Medical Device Podcast? Let us know what topics you want to hear next or leave us a review on your podcast platform of choice. We love your feedback—email us at podcast@greenlight.guru for a personalized reply. Sponsor Message This episode is brought to you by Greenlight Guru , the only MedTech Lifecycle Excellence Platform designed to accelerate product development and ensure clinical compliance. Learn more at www.greenlight.guru .…

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#413: Budgeting Blind Spots: What MedTech Startups Miss—and How Investors See It 35:24

منذ 12 weeks35:24

35:24

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with seasoned MedTech founder and investor Jon Bergsteinsson to unpack a critical—but often overlooked—topic: budgeting in early-stage medical device startups. Drawing from his deep regulatory, clinical, and investment experience, Jon shares the red flags investors look for, the cost categories that founders routinely miss, and why a line item called “compliance” just doesn’t cut it. Whether you’re a startup founder, a regulatory lead, or a project manager, this episode offers a sharp lens into the financial planning realities that can make or break product development and commercialization in MedTech. Key Timestamps 02:34 – Why QMS, regulatory, and clinical are budget afterthoughts for startups 06:45 – What separates experienced vs. inexperienced MedTech founders in budgeting 10:20 – Why software and compliance tools get left out of early budgets 14:12 – How missing budget detail impacts product quality and time-to-market 19:04 – Red flags investors look for in MedTech startup budgets 23:30 – How to improve budgeting accuracy without a CFO 28:10 – Critical cost categories MedTech founders often overlook 35:55 – Advice for recovering from a budgeting oversight 39:40 – Comprehensive checklist of overlooked line items (manual translation, UDI, ISO licenses, and more) 45:00 – Final advice: why networking trumps isolation for smarter budgeting Standout Quotes "Relying on the status quo is never good. There are always ways to do things better." Jon reminds founders and compliance professionals alike that innovation doesn’t stop at the product level—it also applies to budgeting, systems, and team empowerment. "Getting a 510(k) through is just the starting point. Budgeting like everything ends there is a massive red flag." This quote highlights the investor’s perspective on sustainability and long-term thinking—crucial traits in any fundable founder. Key Takeaways Broad Budget Buckets Signal Inexperience Lumping all compliance-related costs under one line item may look tidy but signals to investors a lack of operational depth. Break out line items for QMS, clinical, regulatory, and software tools. Software and Tools Are Not Optional Extras Founders must factor in essential systems—like eQMS, CAD, risk management, and clinical data tools—early in budgeting. Assuming a single hire covers everything is a critical mistake. Budgets Must Reflect Time and Scale Realistically Flat budgets over 2–3 years, or those that assume regulatory costs end at market clearance, raise red flags. Investors expect dynamic budgeting that reflects the realities of growth, post-market surveillance, and team evolution. Outsourcing ≠ All-Inclusive Many startups underestimate the actual costs tied to consultants and CROs, assuming “someone else is handling it.” Always clarify what’s included—and what’s not. Recovery Is Possible—If You Own It If your budget’s off-track, clear communication with your board and investors, a willingness to revise, and a plan for worst-case scenarios are your best tools for regaining credibility. References Jon Bergsteinsson on LinkedIn Etienne Nichols on LinkedIn Greenlight Guru – QMS and Clinical platform for MedTech companies MedTech 101 Why “One Line for Compliance” Doesn’t Cut It Think of compliance like building a house. You wouldn’t budget for the entire construction under “tools and materials”—you’d break it out by framing, plumbing, electrical, permits, inspections, and more. In MedTech, the “compliance house” includes QMS platforms, regulatory consulting, ISO standard licenses, clinical software, and ongoing post-market surveillance costs. Each of these is a critical structural element—and each has its own cost profile. Poll Question: What budgeting category do you think is most overlooked in early-stage MedTech startups? Clinical trial costs Regulatory software/tools Consultant scope and fees Post-market surveillance Have you ever discovered a major budget blind spot after launching your MedTech project? Tell us what you missed and what you learned—email us at podcast@greenlight.guru . We might feature your story in a future episode. Feedback Enjoying the podcast? We want to hear from you! Share your thoughts, leave a review, or suggest a topic you’d love to hear about next. Reach out at podcast@greenlight.guru for a personalized response from our team. Sponsors This episode is brought to you by Greenlight Guru , the MedTech lifecycle platform trusted by medical device companies worldwide. Whether you're budgeting for your first study or scaling to new markets, Greenlight Guru Quality and Clinical helps you move faster while proving safety and effectiveness. Learn more at greenlight.guru .…

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#412: How to Build a QMS That Actually Works: From Startup to Scale in MedTech 16:58

منذ 13 weeks16:58

16:58

In this live episode from the LSI conference in California, Etienne Nichols is joined by Ashkon Rasooli to break down what it really takes to build a high-performing quality management system (QMS) in medtech—from startup chaos to post-market scale. Ashkon shares a phased approach to aligning QMS implementation with product development, explains the concept of "enforcement points," and reveals how founders can reduce the burden of compliance by starting small and planning ahead. If you're navigating regulatory requirements while trying to stay innovative, this episode is your roadmap to smarter, leaner quality. Key Timestamps 00:02 – Introduction to Greenlight Guru and medtech process integration 01:15 – QMS evolution from startup to commercialization 03:00 – Phase-based product development overview (Phases 0–6) 06:35 – Why QMS should follow product needs, not just regulatory triggers 09:10 – Agile vs. proceduralism in quality systems 11:50 – Building a quality culture during the feasibility phase 15:25 – When to implement QMS controls and how to prepare for “enforcement points” 18:40 – Investor-driven and regulatory QMS triggers 21:10 – How early QMS planning saves time and reduces future remediation 26:20 – Ashkon’s final advice for startups: start small and stay proactive Standout Quotes "You’ve got to take the BS—being burdensome—out of QMS." Ashkon Rasooli redefines QMS as a project management tool, challenging the notion that compliance must be a burden. This quote encapsulates his philosophy of proactive, phased implementation that actually enhances product development. "Start small and do a little bit at a time—it won’t seem like a burden." A practical mantra for startups, this advice underscores how a gradual, well-aligned QMS rollout can prevent last-minute fire drills and wasted effort. Top Takeaways Use the "Phase 0–6" Model to Guide QMS Rollout – Align QMS implementation with the stages of product development to ensure each step supports the next. Don’t Wait for Enforcement Points – Start building your QMS before regulators or investors demand it to avoid remediation-heavy implementations. Prioritize Culture Before Controls – In early feasibility, focus on aligning your team with medtech’s safety responsibilities, rather than formal procedures. Procedures Should Support Outcomes, Not Just Check Boxes – Avoid proceduralism by tying every process back to its intended quality objective. Regulatory Strategy = Investor Strategy – QMS maturity is increasingly scrutinized during due diligence. Treat it as a value driver, not just a cost. References Ashkon Rasooli on LinkedIn Greenlight Guru – Quality management software for medical devices Etienne Nichols on LinkedIn – Connect with the host ISO 13485 vs. ISO 9001 – Explains how medical device quality systems build on general standards ISO 14155 Overview – Relevant for clinical validation procedures MedTech 101: What Are “Enforcement Points”? In the context of QMS, enforcement points are moments when external stakeholders (regulators or investors) require proof of formalized processes. Think of it like a driver’s license checkpoint—you may be cruising just fine, but at that moment, you must prove you’re compliant. The earlier you prep for them, the smoother your journey. Poll Question: Where is your company on the QMS journey? A) Pre-feasibility (Phase 0) B) Early product planning (Phase 1–2) C) Preparing for launch (Phase 4–5) D) Post-market and scaling (Phase 6+) E) Not sure where we stand What’s one thing you wish you knew earlier about building your QMS? Share your thoughts at podcast@greenlight.guru . Feedback CTA Enjoying the Global Medical Device Podcast? Help us shape future episodes—leave a review on your favorite platform or email us at podcast@greenlight.guru . We read every message and respond personally! Sponsor Integration This episode is powered by Greenlight Guru , the only quality management software designed specifically for medtech. Whether you're defining your quality policy in Phase 1 or preparing for design transfer in Phase 5, Greenlight Guru helps you stay aligned, compliant, and agile.…

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#411: Unlocking U.S. MedTech Market Access: State-Specific Compliance Pitfalls Medical Device Companies Miss 48:11

منذ 14 weeks48:11

48:11

Many MedTech companies focus heavily on FDA clearance but overlook a critical layer of U.S. market entry: state-level compliance. In this episode, Etienne Nichols speaks with Adam Steadman, CEO of MDD Options, to unpack the real-world challenges that derail commercialization after regulatory approval. From navigating state-specific registration, sales tax laws, and distribution logistics to choosing between direct and distributor-based strategies, Adam shares hard-earned insights for avoiding the "second valley of death" post-clearance. Whether you're a domestic startup or an international company entering the U.S., this episode arms you with a tactical understanding of compliance landmines and scalable go-to-market strategies. Key Timestamps 00:02 – Intro: The real MedTech “valley of death” after FDA clearance 04:45 – Why U.S. state-level registration is misunderstood and overlooked 08:15 – State-level definitions of medical devices and why they differ 11:20 – Strategic go-to-market options: Distribution vs. Direct 17:00 – How regulations vary drastically by state (CA, TX, etc.) 21:50 – The real risks of noncompliance: lawsuits, bad PR, and due diligence failures 26:15 – Why distribution agreements can stall your growth (and how to avoid it) 34:30 – Sales tax & use tax: The hidden compliance trap 39:10 – Logistics, warehousing, and long-term liabilities in contracts 44:55 – Overlooked pitfalls: Secretary of State filings and income tax in 36+ states 51:15 – Software as a Medical Device (SaMD): U.S. compliance still applies 55:30 – Selling to the U.S. government vs. private sector buyers 59:20 – Veterinary devices and why they still need regulatory controls 1:03:10 – What a winning go-to-market strategy actually looks like 1:10:25 – Adam’s final advice to MedTech startups (foreign and domestic) Standout Quotes "You're not entering one country—you're entering 50 states and D.C. Each with its own rules, definitions, and tax laws." —Adam Steadman explains why U.S. MedTech entry requires a state-by-state strategy, especially for international companies. "None of the strategics want your warehouse management system—they want your product, your sales, and your proof of market fit." —Steadman on why building non-core infrastructure slows down commercialization and valuation. Top 5 Takeaways FDA Clearance ≠ Market Readiness – State-level registrations, sales tax laws, and pharmacy board definitions often delay or block commercialization. Distribution Isn’t Always a Shortcut – National distributors may have misaligned incentives and can lock you into exclusivity that hinders growth. Sales Tax is a Regulatory Minefield – 46 states require separate sales tax registration, exemptions tracking, and monthly filings—even if you're tax-exempt. Beware of Long-Term Contracts – Logistics and distribution contracts often lock companies into rigid terms that prevent pivots or acquisitions. Speed to Market Is Strategic – Getting to market fast is often the difference between becoming #1 or #3—and #3 often gets nothing. MedTech 101 What Is “Nexus” and Why It Matters for Sales Tax? “Nexus” refers to the minimum level of economic activity that triggers tax obligations in a given state. For example, selling $100,000 of devices or 200 transactions may establish nexus, requiring you to register for sales tax. Unlike VAT in Europe, U.S. sales tax laws are state-specific, making this a major compliance hurdle for MedTech companies. References & Resources Adam Steadman on LinkedIn Etienne Nichols on LinkedIn MDD Options – Adam’s Company Greenlight Guru Quality Platform Poll Question: Which part of U.S. market entry do you feel least prepared for? State-level licensing Sales tax registration Distribution strategy Logistics & warehousing All of the above Have you faced unexpected delays due to state-level regulations? Share your story—we may feature it in a future episode. Feedback & Contact Enjoying the podcast or have ideas for future topics? We’d love to hear from you! Send your thoughts to podcast@greenlight.guru – we read every message and often reply personally! Sponsor Message This episode is brought to you by Greenlight Guru Quality – a purpose-built QMS platform that keeps you always audit-ready. Organize evidence by requirement, flag gaps, and avoid the scramble before inspections. Don’t get ready— stay ready.…

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#410: Is the MAUDE Database Broken? An Insider’s Take on Adverse Event Reporting Failures 50:21

منذ 15 weeks50:21

50:21

In this episode of the Global Medical Device Podcast , Etienne Nichols and regulatory expert Mike Drues take a critical look at the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. While intended to serve as a vital tool for post-market surveillance, the MAUDE database is fraught with issues—from late reporting and missing data to unclear mission alignment. Mike challenges MedTech professionals to rethink how we engage with the system, exposing how widespread underreporting and data hygiene problems not only weaken safety efforts but also increase legal risk. This eye-opening discussion reveals where the breakdowns are occurring, who’s responsible, and what industry and regulators can do to fix it. Key Timestamps [02:30] What is the MAUDE database, and why does it matter? [06:10] The critical difference between reportable and non-reportable adverse events [11:20] Limitations of MAUDE: Why FDA warns against using it for rate comparisons [17:45] Underreporting, late submissions, and missing data: The disturbing stats [25:00] High-profile companies dominating late reporting violations [32:10] Legal consequences: What expert witnesses look for in MAUDE data [38:50] Is it poor systems or lack of regulatory understanding causing failures? [46:00] Recommendations for manufacturers: What responsible reporting looks like [53:20] How FDA could modernize the MAUDE database to better serve patients [1:01:30] Carrots or sticks: Creating incentives vs. penalties for compliance [1:09:00] Final thoughts: The true mission of MAUDE and how to fulfill it Standout Quotes "A report in the MAUDE database is just a historical record. It doesn’t say why it happened or who’s at fault—just that it happened." — Mike Drues This quote underscores the limited utility of MAUDE reports and why interpretation requires caution. "If you're not a medical device professional without your tools, then you're not really a medical device professional." — Etienne Nichols A poignant reminder that compliance and quality are human-led, not software-enabled by default. Top Takeaways Late Reporting is Widespread and Risky Nearly 30% of MAUDE reports are filed late, with 10% submitted more than six months past due. This creates legal exposure and potential patient harm. MAUDE Is Misused—Despite FDA Warnings Manufacturers commonly use MAUDE for competitive analysis or trend detection, even though the FDA explicitly warns against it. Three Companies Account for Over Half of Late Reports Large, well-resourced companies like Medtronic and Becton Dickinson are responsible for a disproportionate share of noncompliance. Electronic Tools Help, but Culture Matters More Software can support MDR timelines, but organizations still need internal processes and urgency to act responsibly. FDA and Industry Both Need to Evolve Suggestions include AI-driven cross-referencing, tiered reporting urgency, and incentive-based compliance recognition. References FDA MAUDE Database 21 CFR 803.16 – MDR Reporting Requirements Etienne Nichols on LinkedIn MedTech 101: What Is MAUDE and Why Should You Care? Think of the MAUDE database as a public logbook of adverse events involving medical devices in the U.S. Unlike peer-reviewed literature or formal recalls, MAUDE captures both mandatory and voluntary reports—from manufacturers, healthcare professionals, and even patients. However, it's not a perfect dataset. Think of it like Yelp for medical device failures: informative, but filled with inconsistencies, duplicates, and vague reviews. Poll Question: How confident are you in your organization’s ability to report adverse events to the FDA on time and accurately? Have you ever tried to use the MAUDE database for competitive analysis or submission support? Share your experience—was the data helpful, misleading, or incomplete? Feedback Have a topic suggestion or feedback on today’s episode? We want to hear from you. Email us at podcast@greenlight.guru and get a personal response from our team. Sponsors Today’s episode is brought to you by Greenlight Guru , the only MedTech-specific QMS software that empowers companies to simplify complaint handling, streamline MDR submissions, and improve audit readiness. If you're ready to evolve beyond spreadsheets and silos, visit greenlight.guru .…

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#409: How Iterative Management Transforms MedTech Teams: Faster Execution, Smarter Decisions 23:15

منذ 16 weeks23:15

23:15

In this episode recorded live at LSI Dana Point, Etienne Nichols sits down with Ed Muzio, author of Iterate , to explore how iterative management helps MedTech companies move faster as they scale. Muzio breaks down the pitfalls of traditional management—including siloed execution and backward-looking metrics—and offers a proven alternative grounded in over 70 years of research. With real-world analogies, like orchestras and dashboards, Muzio explains how leaders can create alignment, drive faster decisions, and unlock collaborative problem-solving by focusing on the future instead of the past. Whether you're part of a startup or an established MedTech firm, this episode delivers actionable strategies to help your team iterate with purpose. Key Timestamps [00:01] Introduction and sponsor message from Greenlight Guru [01:13] Meet Ed Muzio and the premise of Iterate [03:15] Why most management meetings don’t drive real action [06:40] The “Alice” video case study and how it exemplifies iterative management [11:50] Common objections and barriers to implementing iterative processes [17:00] Using forward-looking data instead of status updates [22:08] MedTech example: anticipating 510(k) review delays [29:15] Making decisions early to gain planning time [34:20] How to get started if you’re a small or early-stage company [37:40] Cultural barriers in iterative team models [41:20] Handling matrixed environments and CEO-level priorities [47:10] Why clarity of decision-makers matters in early teams [51:45] The biggest mistake mature companies make in team meetings [55:05] Final advice: focus on behavior, not buzzwords Standout Quotes “If you walk into a meeting and it's 26 minutes in and you haven’t made a decision yet—and that’s normal—you’re probably not solving anything.” —Ed Muzio on the inefficiency of status-only meetings in traditional management culture. “We don’t need to forecast history. We need to plan around the future.” —Ed Muzio explaining why forward-looking metrics are the only actionable data in iterative teams. These quotes challenge conventional meeting norms and emphasize a proactive mindset crucial to success in fast-moving MedTech environments. Top Takeaways Backward-looking metrics kill momentum. Most leadership teams spend meetings reviewing past progress. Instead, focus on forecasting future outcomes and addressing variances before they become problems. Accountability must be systemic, not personal. A team can only normalize issue-raising if the entire culture shifts to expect it—making it safe and standard to surface concerns early. “Succeed or fail together” breaks silos. When departments align to shared goals, cross-functional collaboration becomes natural. Incentives that isolate progress undermine execution speed. Don’t vote—decide. In small teams, designate a clear decision-maker and avoid democratic processes that lead to politicking instead of clarity. Adopt flexible systems over rigid charts. Org charts don’t reflect reality. Iterative management embraces the messiness of matrixed teams and adapts meetings and collaboration structures fluidly. References Iterate by Ed Muzio – Book on accelerating team alignment and decision-making IterateNow.com – Access free videos and practical management tools from Ed Muzio Etienne Nichols on LinkedIn – Connect with the podcast host MedTech 101: What Is Iterative Management? Iterative management is like adjusting your GPS route in real time—rather than simply reviewing where you’ve been, you keep making small course corrections to reach the goal faster. In a MedTech context, this means shifting focus from milestone recaps to real-time issue resolution, involving all departments in forward-looking planning. Visual tools like pragmatic dashboards (with projected vs. actual timelines) help clarify where corrections are needed. Poll Question: What’s the biggest obstacle your team faces in solving problems before they escalate? Status-focused meetings Lack of cross-functional alignment Fear of raising issues Unclear decision-making authority Engagement Prompt: Have you ever worked in a team where raising early concerns was encouraged —not penalized? Share your experience and tag a team leader who made it work. Feedback & Listener CTA Enjoying the podcast? We'd love to hear your feedback. Email us at podcast@greenlight.guru with your thoughts, questions, or suggestions for future guests. Every email gets a personal response! Sponsors This episode is brought to you by Greenlight Guru —the only quality management system built specifically for MedTech. Want your design history file audit-ready and effortlessly connected across departments? Learn more at www.greenlight.guru .…

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#408: What MedTech Startups Miss: Design Mistakes, Risk Testing & the Myth of the Quick Exit 9:27

منذ 17 weeks9:27

9:27

In this live episode from the LSI conference, Etienne Nichols sits down with Justin Bushko—known as the "MedTech Man" and author of Medical Device Fireside Chats —to dive into what separates thriving medical device companies from those that fail. From costly engineering missteps like ignoring tolerance stack-ups to the human factors issues that derail usability in the OR, Justin shares battle-tested advice based on his experience reviewing hundreds of device designs. He also delivers a wake-up call to startups overly focused on licensing or acquisition as the endgame. Whether you're an engineer, founder, or CEO, this episode offers critical insights into how to build a product that works—and a company that lasts. Key Timestamps 00:00 – Introduction & Greenlight Guru Sponsor Message 01:26 – Live from LSI: Introducing Justin Bushko 02:55 – Why Early-Stage Engineering Mistakes Derail Companies 04:12 – The Critical Role of DFM and Tolerance Analysis 06:20 – Real-World Usability Failures: FDA Warning on Cranial Fixation Devices 08:10 – Human Factors Oversights & Surgeon Behavior 10:25 – What CEOs Should Focus On vs. Engineers 12:20 – Economic Buyers, KOLs, and Commercialization Challenges 14:05 – Don’t Chase the Exit: Why Founders Should Build for Longevity 16:00 – Final Thoughts and Takeaways Standout Quotes “If your partners can’t explain how and why they did your tolerance analysis, they probably didn’t do it right—and it’ll cost you nine months later.” —Justin Bushko, on the hidden dangers of relying too heavily on outsourced design partners. “Founders aiming for a quick exit send the wrong message. Build something sustainable. Acquisition should be a byproduct—not the goal.” —Justin Bushko, challenging the exit-first mindset common in early-stage MedTech. Top Takeaways DFM & Tolerance Analysis Are Non-Negotiable: Skipping detailed design-for-manufacturing and tolerance stack analysis often leads to failure right before tooling and commercialization—when funds are already tight. Human Factors Must Be Built-In Early: Surgeons may not use your product as intended. Validate with a wide range of KOLs to uncover unintended use or misuse. Test for High-Risk Use Cases Early: For devices like inserters, test mechanical thresholds that could lead to field failures. Don’t wait until post-market feedback. Understand Economic Buyers, Not Just KOLs: A surgeon’s support doesn’t guarantee adoption. You need champions who can advocate to hospital boards and procurement teams. Stop Chasing Exits—Build Real Companies: Investors and acquirers see through the “quick flip” mentality. A sustainable business model attracts more serious interest. References Greenlight Guru – Sponsor and end-to-end MedTech quality management platform Justin Bushko on LinkedIn Etienne Nichols on LinkedIn Medical Device Fireside Chats – Justin Bushko’s Book (Amazon) (If mentioned/linked on-site) MedTech 101: What is Tolerance Stack-Up Analysis? Imagine building a puzzle where each piece is just slightly off in size—by the time you put it all together, nothing fits. That’s what tolerance stack-up is about. Every part in a device has a manufacturing variation. If those tolerances aren’t analyzed cumulatively, you can end up with a product that doesn’t assemble or fails under stress. Tolerance analysis helps predict and prevent these compounding errors before they happen. Poll Question: What’s the biggest product development risk in early-stage MedTech? Tolerance stack-up issues Ignoring human factors Economic misalignment with buyers Rushing to an early exit Discussion Prompt: Have you ever seen a product fail in the field due to a design assumption? Share your story and how it changed your approach. Feedback Enjoyed the episode? Want to hear more from product engineers, founders, or regulators? Let us know! Send your feedback, guest ideas, or questions to podcast@greenlight.guru — we read every email and respond personally. Sponsor Mention This episode is brought to you by Greenlight Guru , the only MedTech-specific quality management platform. Whether you’re an engineer working through DFM or a CEO planning your go-to-market strategy, Greenlight Guru helps you manage compliance, risk, and innovation—all in one place.…

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#407: Cybersecurity in MedTech: FDA Compliance, Patient Safety & the Hidden Risks You’re Missing 42:21

منذ 18 weeks42:21

42:21

Christian Espinosa, founder of Blue Goat Cyber and leading voice in medical device cybersecurity, joins Etienne Nichols to unpack the urgent and often misunderstood topic of cybersecurity in MedTech. From FDA’s 2023 regulatory overhaul to real-world hacking scenarios that could harm patients, Christian provides practical advice for innovators, RA/QA professionals, and software teams. He also shares why waiting until the last minute on cybersecurity could cost startups millions—or even kill a project entirely. Whether you're a quality professional trying to build compliant systems or an innovator racing toward FDA submission, this episode lays out exactly what you need to know to stay ahead of cyber threats and within regulatory guardrails. Key Timestamps: 00:01 – Intro to guest Christian Espinosa and Blue Goat Cyber 06:28 – Why medical device cybersecurity is different from traditional IT security 11:49 – Real-world hacking example: acne laser device turned skin-burner 13:57 – FDA expectations post-September 2023: what changed 17:12 – Secure boot: a microcontroller mistake that derailed a launch 20:35 – Common cybersecurity vendor mistake MedTech companies make 23:40 – SBOM: Software Bill of Materials and why it's legally critical 27:58 – Cyberattacks in hospitals: assuming a hostile network 35:44 – AI in medical devices: data bias and cybersecurity challenges 41:10 – Developers ≠ cybersecurity experts: the training gap nobody talks about 45:20 – What RA/QA professionals need to know now 49:30 – Why cybersecurity must be iterative, not a final-phase add-on 55:20 – Espinosa's final advice for MedTech professionals 57:52 – The story behind “Blue Goat Cyber” Standout Quotes: “Cybersecurity for medical devices isn’t about data breaches—it’s about patient harm. You could paralyze someone or misdiagnose sepsis. This isn’t theoretical.” — Christian Espinosa, on the real risks of insecure devices “Most developers don’t understand cybersecurity. We assume they do—but that’s like expecting an architect to be a locksmith.” — Christian Espinosa, on why so many devices fail security assessments Top Takeaways: Cybersecurity isn’t just about data—it's about patient safety. From burning skin to missed sepsis diagnoses, vulnerabilities in devices have real-world harm potential. FDA now requires more than just a basic security plan. Post-September 2023 rules mandate testing (SAST, DAST, fuzzing), SBOMs, and risk assessments tied to patient harm. Start cybersecurity planning during the requirements phase. Hardware like microcontrollers must support secure boot and other protections—retrofits can cripple product plans. Iterate cybersecurity like any core development activity. One-time testing near submission is too late; build security into your pipeline just like QA or usability. Traditional cybersecurity vendors aren’t enough. Many fail to meet FDA’s nuanced expectations for medical devices, causing costly submission rejections. References & Resources: Christian Espinosa on LinkedIn Blue Goat Cyber Etienne Nichols on LinkedIn MedTech 101 – Understanding SBOM (Software Bill of Materials): Think of an SBOM like a nutrition label on food. Just as you want to know if a product contains allergens or preservatives, FDA wants to know what libraries and components are in your software. A clean, complete SBOM identifies both security vulnerabilities and potential licensing conflicts—like borrowing ingredients you’re not legally allowed to use. Want a visual explanation? Consider a flowchart showing third-party libraries linking into your main software repository, flagged with vulnerability scores. Poll Question: Is cybersecurity currently integrated into your product development process— A) From Day 1 B) Only near submission C) We outsource and hope for the best D) What cybersecurity? What’s your biggest challenge when it comes to building cybersecurity into your product lifecycle? Email us your thoughts at podcast@greenlight.guru . Feedback: If this episode sparked new insights or raised questions, we’d love to hear from you. Send us your feedback or suggest a topic at podcast@greenlight.guru . We personally respond to every email and appreciate your ideas for future guests and discussions. Sponsored by Greenlight Guru: Most companies spend more time preparing for audits than in the audit itself. Greenlight Guru Quality lets you link cybersecurity and quality evidence directly to requirements, making you “always audit-ready.” Learn more at www.greenlight.guru .…

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